Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited documentation, application time not according to OECD TG 404. The test results from the ear are not taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Principles of method if other than guideline:
BASF Test
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphate
EC Number:
231-984-1
EC Name:
Ammonium sulphate
Cas Number:
7783-20-2
Molecular formula:
H3N.1/2H2O4S
IUPAC Name:
Monochloramine generated from ammonium sulphate and a chlorine source
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 80%
Duration of treatment / exposure:
up to 20 hours (back)
Observation period:
8 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at the end of the respective application period

SCORING SYSTEM:
BASF scoring system, convertible to Draize score system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: 20 h exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 20 h exposure
Irritant / corrosive response data:
Barely visible skin erythema (equivalent to a Draize score of 0) was noted at 24 hours after exposure when test substance was applied for 5 minutes, 15 minutes or 20 hours. No effects were noted at 8 days after the end of the exposure or after exposure to the test substance for only 1 minute. Neither scaling nor edema were noted at any observation time.
Other effects:
No mortality occurred and there were no clinical signs of toxicity observed.

Any other information on results incl. tables

Table: Draize scores

Application

site

Application

time

Findings at

24 hours

8 days

Erythema

edema

Back

1 min

no findings

no findings

5  min

1

0

no findings

15 min

1

0

no findings

20 h

1

0

no findings

Applicant's summary and conclusion